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FDA 510(k)

NextAR™ TSA Platform

K-Number: K232280 · 2023-10-29

ApplicantMedacta International S.A.
Decision Date2023-10-29
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NextAR™ TSA Platform is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2023-10-29 under 510(k) number K232280. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NextAR™ TSA Platform?

NextAR™ TSA Platform is a medical device that received FDA 510(k) clearance on 2023-10-29. The listed applicant is Medacta International S.A.. The 510(k) number is K232280.

When did NextAR™ TSA Platform receive FDA 510(k) clearance?

NextAR™ TSA Platform received FDA 510(k) clearance on 2023-10-29, under 510(k) number K232280.

Who is the listed applicant for NextAR™ TSA Platform?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NextAR™ TSA Platform?

The FDA product code for NextAR™ TSA Platform is SBF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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